Evaluation of the Potential Effects of SSR149415 on the Hypothalamic-pituitary-adrenal Axis in Outpatients With Major Depressive Disorder

Major Depressive Disorder Clinical Trial

— NAPA  

Official title:

A Double-blind, Placebo-controlled Study Evaluating the Pharmacodynamic Effects of Two Fixed Doses of SSR149415 (250 mg Bid and 100 mg Bid) on Hypothalamic-pituitary-adrenal Axis Function in Outpatients With Major Depressive Disorder

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01606384
• Other study ID #: PDY5467
• Status: Completed
• Phase: Phase 2
• First received: May 23, 2012
• Last updated: May 24, 2012
• Start date: December 2006
• Est. completion date: August 2007

Study information

• Verified date: May 2012
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

Primary Objective:

• To evaluate the effects of two fixed doses of SSR149415 (250 mg bid and 100 mg bid) on hypothalamic-pituitary-adrenal axis function in patients with major depressive disorder.

Secondary Objectives:

• To evaluate the tolerability and safety of SSR149415 in patients with major depressive disorder.

• To evaluate the efficacy of two fixed doses of SSR149415 compared to placebo in patients with major depressive disorder.

• To evaluate plasma concentrations of SSR149415.

Description:

The study consisted of three segments (A, B and C). Segment A was a 1 to 4-week, drug-free, screening and baseline period. Segment B was a 4-week, double-blind period. After the last dose of double-blind study medication in Segment B, all patients had to enter Segment C, a 1-week drug-free, follow-up period.

The total study duration for one patient participating in all segments of the study was 6 weeks.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: August 2007
• Est. primary completion date: August 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 64 Years

Eligibility

Inclusion criteria :

• Diagnosis of major depressive disorder as defined by the Diagnostic and Statistical Manual of Mental Disorders, 4th Edition-Text Revision (DSM-IV-TR) and the Mini International Neuropsychiatric Interview (MINI) criteria.

Exclusion criteria:

• Outpatients unwilling to be hospitalized a total of 6 nights and 8 days.

• Total score of less than 21 (<21) on the 17-item Hamilton Depression Rating Scale (HAM-D) at Visit 1 (Day -7) or Visit 5 (Day -1).

• Patients whose current depressive episode is diagnosed with psychotic features, catatonic features, seasonal pattern or post-partum onset or is secondary to a general medical disorder.

• Patients with alcohol dependence or abuse or substance dependence or abuse in the past 12 months according to the MINI, except nicotine or caffeine dependence.

• Patients who have used the following prior to entry into Segment B: any antipsychotic within 3 months; fluoxetine within 1 month; any monoamine oxidase inhibitor (MAOI) within 2 weeks; any other antidepressant, anxiolytic, sedative-hypnotic, or mood-stabilizer (lithium, anticonvulsants) within 7 days except permitted concomitant medications

• The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Major Depressive Disorder

Intervention

Drug:
• VASOPRESSIN V1B RECEPTOR ANTAGONIST (SSR149415)
Pharmaceutical form: Capsule Route of administration: oral
• Placebo
Pharmaceutical form: Capsule Route of administration: Oral

Locations

Country	Name	City	State
United States	Sanofi-Aventis	Bridgewater	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cortisol plasma concentration response to Corticotropin releasing factor (CRF) administration before and after 27 days of dosing		4 weeks	No
Secondary	Adrenocorticotropic hormone (ACTH) plasma concentration response to CRF administration before and after 27 days of dosing		4 weeks	No
Secondary	Number of patients with adverse events		Up to 6 weeks	Yes
Secondary	Changes in Hamilton Depression Rating Scale (HAM-D) depressed mood, factor and core items scores		Baseline, 4 weeks	No
Secondary	Changes Clinical Global Impression (CGI) Severity and Improvement scores		Baseline, 4 weeks	No